The Senate Health, Education, Labor, and Pensions (HELP) Committee Dec. 7 held a hearing entitled, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation.”
Similar to a House Energy and Commerce hearing held one week earlier, National Institutes of Health (NIH) Director Francis Collins, MD, PhD, and Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, provided a status update on various provisions included in the 21st Century Cures Act (P.L. 114-255) [see Washington Highlights, Dec. 9, 2016].
Committee Chair Lamar Alexander (R-Tenn.) began the hearing by highlighting that the 21st Century Cures Act passed the Senate about one year from the hearing date saying, “The law passed last year to boost biomedical research at a time of limitless opportunity.” He recalled that at a Senate Appropriations hearing in 2016, “Dr. Collins offered ‘bold predictions’ for future medical advances if we continue funding NIH and ensure FDA has the tools it needs,” and that the purpose of this hearing was to find out from Drs. Collins and Gottlieb how the implementation of the law was going.
Among the items in his written testimony, Dr. Collins discussed how the NIH and biomedical research community has “been concerned about the long-term stability of the biomedical research enterprise.” He also described that, “As a consequence of NIH’s loss of more than 20 percent of its purchasing power from 2003 to 2015, researchers were forced to vie for limited resources, leading to a hypercompetitive environment,” pointing out that the current environment is “particularly challenging for many new- and mid-career investigators.”
Similar to the testimony provided in the House Energy and Commerce hearing, Dr. Gottlieb discussed FDA’s new Oncology Center for Excellence, minimal risk clinical investigations, and regenerative medicine, among other topics.
The Senate HELP Committee Dec. 13 held a subsequent hearing on the 21st Century Cures Act to discuss the mental health needs of the nation. Testifying on behalf of the administration was Elinore McCance-Katz, MD, PhD, assistant secretary for mental health and substance use, Substance Abuse and Mental Health Services Administration.